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Brief Title: Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)
Official Title: A PHASE Ib/IIa STUDY OF COMBINATION THERAPY WITH GEMCITABINE AND ATU027 IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC ADENOCARCINOMA
Study ID: NCT01808638
Brief Summary: The purpose of the study is to evaluate a new treatment strategy for advanced pancreatic cancer disease by combining the new investigational medicinal product Atu027 with the standard chemotherapeutic gemcitabine. This combination aims at enhancing gemcitabine´s anti-tumor activity with Atu027. The objectives of this clinical trial are to evaluate safety and activity of two Atu027 schedules in combination with standard gemcitabine treatment in patients with advanced or metastatic pancreatic adenocarcinoma.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CharitÊ - Universitätsmedizin Berlin CharitÊ Centrum fßr Tumormedizin, Berlin, , Germany
Klinikum Dortmund gGmbH Medizinische Klinik Mitte, Dortmund, , Germany
Universitätsklinikum Freiburg, Innere Medizin II, Freiburg, , Germany
Medizinische Klinik III - Hämatologie/Onkologie Marienhospital Herne, Herne, , Germany
Klinikum Kassel GmbH Medizinischen Klinik IV;Onkologie,, Kassel, , Germany
Klinikum NĂźrnberg Nord Medizinische Klinik 5, NĂźrnberg, , Germany
Klinik und Poliklinik fßr Innere Medizin I Universitätsklinikum Regensburg, Regensburg, , Germany
Klinikum Stuttgart Klinik Hämatologie, Onkologie und Palliativmedizin, Stuttgart, , Germany
Universitätsklinikum Ulm Zentrum fßr Innere Medizin, Ulm, , Germany
Name: Dirk Strumberg, Prof.Dr.med.
Affiliation: Medizinische Klinik III - Hämatologie/Onkologie Marienhospital Herne
Role: PRINCIPAL_INVESTIGATOR